The goal of this clinical trial is to learn whether changing the diet can help improve gut health and support recovery from immune-related side effects caused by immune checkpoint inhibitor (ICI) cancer treatment in adults with solid tumors who develop moderate to severe immune-related side effects that require steroid treatment.
The main questions it aims to answer are:
Does a high-fermented food diet or a high-fiber resistant starch supplement change the gut microbiome (the bacteria and other microorganisms that live in the digestive tract) during treatment? Does either dietary approach improve gut microbiome diversity and function by the end of the 7-week intervention period?
Researchers will compare participants assigned to a high-fermented food diet with participants assigned to high-fiber resistant starch supplementation to see if one approach leads to greater improvements in the gut microbiome and related biological measures.
Participants will:
Be randomly assigned to 1 of 2 dietary intervention groups:
High-fermented food diet High-fiber resistant starch supplement Follow their assigned diet for 7 weeks, starting when their ICI treatment is restarted.
Provide stool samples before the intervention begins and regularly throughout the study.
Have blood samples collected at the start of the study and approximately every 3 to 4 weeks during participation.
Provide skin and mouth swab samples at the beginning of the study and again at Week 7.
Complete food diaries and symptom assessments during the study. Participate in a 2-week follow-up period after completing the dietary intervention.
Researchers will also evaluate the safety of the dietary interventions, whether immune-related side effects return, how the immune system responds, and how closely participants follow their assigned diet.
Be willing and able to provide written informed consent.
Adult ≥ 18 years of age, willing and able to provide blood and stool specimen and comply with dietary modification, as well as willing to fill out study required questionnaires (paper or electronic and web-based).
Patients must have any type of electronic device such as a smartphone, tablet, or computer, etc. that can access the internet.
Self-reported willingness to adhere with dietary intervention.
Use of systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral) within the last 14 days
Cytokines
Methotrexate or immunosuppressive cytotoxic agents, unless the regimen is deemed appropriate by the study investigator (e.g., use of low-dose hydroxychloroquine may be permitted at the investigator's discretion)
Regularly taking probiotics, fiber supplements, or any other medication or prebiotic dietary supplement that could affect the study outcome as determined by the principal investigator and unable/unwilling to discontinue for the study. These agents must be discontinued at least 14 days prior to the start of the diet
Parallel
High-Fermented Food Diet
BehavioralParticipants will consume a high-fermented food diet consisting of at least 6 servings of fermented foods per day for 7 weeks. Participants will receive dietary counseling and regular follow-up with a nutritionist to support adherence to the assigned dietary intervention.
HI-MAIZE 260 Resistant Starch
Dietary supplementParticipants will receive HI-MAIZE 260, high-amylose cornstarch resistant starch dietary fiber supplement, daily for 7 weeks. Participants will receive dietary counseling and regular follow-up with a nutritionist to support adherence to the assigned dietary intervention.
Change in Gut Microbiota composition
To longitudinally assess changes in gut microbiota composition, in patients with solid tumors who develop grade ≥2 irAEs during ICI therapy and undergo dietary modification with either high-fermented foods (Arm 1) or high-fiber supplementation (Arm 2).
Incidence of Adverse Events related to dietary intervention
The incidence and severity of adverse events related to dietary intervention will be graded per CTCAE v5.0.
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score
Tolerability will be assessed using the Gastrointestinal Symptom Rating Scale at baseline and every 2 weeks throughout the study period. Gastrointestinal Symptom Rating Scale (GSRS) Score is a 15-item patient-reported measure of gastrointestinal symptom severity. Items are scored from 1 (no discomfort) to 7 (very severe discomfort). Total scores range from 15 to 105, with higher scores indicating more severe gastrointestinal symptoms and a worse outcome.
Incidence of new immune-related adverse events following ICI re-initiation
New grade ≥2 irAEs will be monitored by organ system following ICI re-initiation, including severity grading per CTCAE v5.0
Changes in Circulating Immune Cells
Changes from baseline to end of intervention will be assessed in the circulating innate immune cells. Measurements will be obtained at baseline (Week -2 to -1), Week 4, Week 7, and post-intervention (Week 8 or 9).
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